Diabetes mellitus is one of the gravest medical and social problems, as it continuously spreads among all population segments, and complications associated with its progression represent a threat to a patient's life (blindness, kidney failure, diabetic gangrene of the extremities, myocardial infarction, apoplexy, etc).
According to the opinion of World Health Organization experts diabetes mellitus currently is a problem of all ages and countries, ranking third among the direct causes of death after cardiovascular diseases and cancer. At the moment there are about 110-120 million diabetics on our planet. Presumably, in 12-15 years the number will double.
Diabetes mellitus is a group of metabolic disorders characterized by hyperglycaemia which results from defects in insulin secretion, insulin action or a combination thereof. The most prevalent is non-insulin dependent diabetes (type II diabetes mellitus) caused by the violation of insulin secretion or the mechanisms of its interaction with tissue cells.
Numerous researches worldwide are focused on finding effective ways of the treatment for diabetes. It is proved that for every percentage point of glycated haemoglobin decrease the risk of the development of microvascular complications (retinopathy, nephropathy) is reduced by 35%. In addition, glycaemic control, along with the blood pressure normalization significantly reduces the risk of the development of coronary heart disease, cerebrovascular disease, and peripheral arterial disease in patients suffering from type II diabetes. Proceeding from this, the main goal of the treatment of the disease is to provide the most possibly complete recovery from carbohydrate metabolism, which can be achieved through creating and applying new and safe medicines, in particular of plant material, and through the technologies for manufacturing thereof.
It was found by the folk medicine and the research of scientists and experts in the search and selection of promising plants for producing hypoglycaemic activity substances, that some of the legume family members possess properties exactly like these. In particular, it is due to essential amino acids including arginine present in the fruit pods. Experimental and clinical studies have shown that extracts of the bean fruit pods reduce the amount of sugar in blood. It is methods for preparing biologically active substances that are of crucial importance to create effective diabetes treatment and prevention means of this plant material.
A method for producing an anti-diabetic agent of a fine cut mixture of dry plants, including bean pods is described in the Russian Federation patent 2131740 for an invention (publ. Jun. 20, 1999) and comprises the steps of: pouring 10 g of plant material with 400 ml of boiling water in an enamel vessel and conditioning in a water bath for 20 minutes, cooling the resulting infusion at room temperature for at least 45 minutes and filtering it through a cheesecloth, dividing the prepared infusion into 3 equal portions and taking one portion 3 times a day 30 minutes before taking meals in the course of 20-30 days.
A method for producing an anti-diabetic tea, comprising a plant material mixture, including bean pods is described in the Russian Federation patent 2284829 for an invention (publ. Oct. 10, 2006) and comprises the steps of: feeding fine cut and sieved material into a mixer, mixing it thoroughly and packing into 2 g paper filter bags. To prepare a tincture one of the filter bags is poured with boiled water, ingrained for 10-15 minutes, cooled to room temperature, after which it is taken 3 times a day.
A method for producing a diabetics prevention and maintenance therapy means is described in the Russian Federation patent 2002103852 for an invention (publ. Oct. 10, 2003) and comprises the steps of: extracting a fine cut mixture of plant material, including bean pods, repeatedly with water under heating, concentrating the combined extracts subsequently at a temperature of 38°-42° C. after separating the impurities, and drying them at 160°-170° C. at the dryer inlet and 70°-75° C. at the dryer outlet.
A method for producing a complex of biologically active compounds possessing a hypoglycaemic effect, is described in the Ukrainian patent 7005 for an invention (publ. Mar. 31, 1995) and comprises the steps of: performing the extraction of plant material with aqueous ethanol, evaporating and purifying the resulting product with ethanol followed by drying, wherein it is bean herb (Phaseolus vulgaris L.) that is subjected to extraction at a material:extractant ratio of 1:2.5-1:3, the resulting extract being evaporated to 1/10-1/11 of the initial volume.
The closest prior art of the method as claimed is a method for producing agents exhibiting hypoglycaemic activity described in the Ukrainian patent 48031 for an invention (publ. Aug. 15, 2002) and comprising the extraction of golden gram herb with 50% ethanol at a material to extractant ratio of 1:8-1:10, the resulting extract being concentrated to 1/18-1/20 of the initial volume, and after cleaning with alcohol the aqueous residue being treated with methylene chloride.
Among the main draw backs of the cited prior arts one should consider their complexity, duration, and considerable labour intensity, as well as the use of extracting agents hazardous to human health in the course of their implementing. Additionally, it should be noted that the primitivity of the described prior art methods for extracting the biologically active substances such as the plant material heat treatment with hot or boiling water, followed by maceration, causes decomposition of biologically active substances, thus reducing the implementation efficiency of the target product produced according to the methods.
The object of the invention is to develop a cost-effective method for producing a complex of biologically active substances with a high hypoglycaemic activity level, wherein the implementation of the method would enable to simplify and shorten the production process, as well as to reduce the complexity thereof.